欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0163/001
药品名称
Zopiclon CF 7,5 mg
活性成分
Zopiclone 7.5 mg
剂型
Coated tablet
上市许可持有人
Stada Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Germany (DE)
Denmark (DK)
Belgium (BE)
Luxembourg (LU)
Austria (AT)
Imostad 7,5 mg - Filmtabletten
France (FR)
Italy (IT)
Sweden (SE)
Poland (PL)
许可日期
1999/08/16
最近更新日期
2024/11/26
药物ATC编码
N05CF01 zopiclone
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
1_3_1 cc Labelling_05_2016
Date of last change:2024/09/06
Final PL
|
PL_Zopiclone_NL163_20131021_AR CTS
Date of last change:2024/09/06
Final SPC
|
SmPC_Zopiclone_NL163_20131021_AR CTS
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase